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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Heart / Stent
Title   HUD study using CORONARY STENT GRAFT (Heart / Stent)
Description   This is not a research study. The JOMED stent is an FDA-approved device under the Humanitarian Use Device (HUD) regulations.
IRB Number   Pro163
Inclusion/Notes   INCLUSION:
  • Patients having degenerative spondylolisthesis or retrolisthesis (up to Grade I)
    AND/OR
    Patients having lateral or central spinal stenosis or other stenosing lesion as diagnosed by radiculopathic signs, neurogenic claudication or imaging studies.

  • Candidate for single-level or contiguous two-level PLF between L1-S1.

  • Patients have a predominate component of leg rather than back symptoms; symptoms include pain, muscle weakness, and/or sensation abnormality as evidenced by patient history and diagnostic studies.

  • Patients may require decompression at the levels considered for treatment.

  • Pre-operative leg pain score > 40 mm on a 100 mm Visual Analog Scale (VAS).

  • Leg pain must be unresponsive to conservative (non-surgical) management for a minimum of 3 months.

  • Pre-operative Oswestry score > 30 indicating at least moderate disability.

  • Skeletally mature individual between ages 20 and 80.

  • Must be willing and able to comply with study requirements; including willing and able to sign a study-specific, IRB-approved informed consent form, complete necessary study paperwork and return for required follow-up visits.

EXCLUSION:
  • Primary diagnosis of discogenic back pain at affected levels as evidenced by a larger back than leg pain component. In the event of multi-level pathology a discogram should be considered.

  • Patients with leg pain due to etiologies other than those listed above, such as trauma, peripheral vascular disease and neuropathy should be excluded.

  • Degenerative scoliosis >10° at the affected motion segment.

  • Supplemental interbody column support (e.g., bone graft, spacers or fusion cages) is planned at the affected level(s).

  • Greater than Grade I spondylolisthesis or retrolisthesis at the affected level(s).

  • Radiculopathic signs from more than two contiguous or two noncontiguous vertebral body segment(s).

  • Previous lumbar fusion attempt(s), previous total facetectomy or trauma at the affected level(s).

  • Gross obesity defined as exceeding ideal weight by greater than 40% (measurement details are given in Appendix A).

  • Active local or systemic infection.

  • Advanced osteoporosis as evidenced by plain film radiographs or history of fractures and confirmed by DEXA scan of < -2t for age group. All women over 50 and men over 60 should have a DEXA scan to confirm adequate bone density.

  • Receiving immunosuppressive or long-term steroid therapy.

  • Active hepatitis (viral or serum) or HIV positive, renal failure, systemic lupus erythematosus, or any other significant medical conditions which would substantially increase the risk of surgery.

  • Documented history of titanium alloy, PET or PCU allergy, or intolerance.

  • Active malignancy or other significant medical comorbidities.

  • Current chemical dependency or significant emotional and/or psychosocial disturbance that may impact treatment outcome or study participation as evidenced by three or more positive Waddell Signs.

  • Pregnancy.

  • Incarceration.

  • Severe muscular, neural or vascular diseases that endanger the spinal column.

  • Missing bone structures, due to severely deformed anatomy or congenital anomalies, which make good anchorage of the implant impossible.

  • All concomitant diseases that can jeopardize the functioning and success of the patient.

  • Vertebral fractures.

  • Treatment of the thoracic and cervical spine.

  • Severely deformed anatomy due to congenital anomalies.

  • Paralysis.
Status   Recruiting
Location   Texas Health Presbyterian Hospital Dallas
Principal Name    James Byung R. Park MD
Contact Name   Zoey Terral at zoecarson@texashealth.org

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